US Regulatory Advertising and Promotion Medical Device Reviewer

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
October 03 2018
Ref
43625BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
The US Regulatory Advertising and Promotion medical device and combination drug/device reviewer is responsible for demonstrating regulatory leadership and influence to advise the US Commercial business on executing compliant advertising and promotional materials for medical devices, including software product and/or mobile medical applications. In this role you will develop effective partnerships with Marketing and Business Communications working along with other cross-functional partners to consistently and efficiently develop and deliver accurate, balanced, and substantiated information about medical devices, including software product and/or mobile medical applications, and combination drug/device products to enable informed decision making by our US customers (patient, provider and payer).

Some of your responsibilities will include:Provide effective leadership and regulatory expertise to Lilly partners (80% of time)
    Accomplished by working with applicable US Marketing Teams and Business Communications to ensureCompliance with all applicable regulations, internal policies and quality systemsHigh quality, timely and decisive regulatory advice to allow business partners to make well-informed decisionsDevelopment of communications that educate customers about Lilly medical devices including software product and/or mobile medical applications by introducing multiple alternative approaches that may meet the business objectives while maintaining compliance with applicable regulations and internal policiesSupport implementation of the promotional material quality system, including setting appropriate direction with US Marketing Team for development, review and approval of product communications within the established processesProvide timely completion of impact assesments for deviation management and input into change controls related to promotional materialAttend US Marketing Team meetings regularly and participate actively in making recommendations regarding proposed promotional activity plansDevelop relationships with personnel in other Lilly functional areas (i.e., marketing, device development, medical, health outcomes, legal, labeling, compliance, quality etc.) to effectively influence the implementation of appropriate promotional messagesConstructively challenge teams to reach the best solutions to issues. Demonstrate strong problem-solving skills and ability to address and effectively communicate complex regulatory issuesProvide input into risk mitigation strategies to inform and influence business leaders by monitoring and communicating factors and trends in the external environment related to advertising and promotion topics from FDA and FTC actions and Company learning through interactions with FDAAdvise business partners on impact of new FDA and FTC Guidances and FDA social scientist research publications to promotional activities and practicesProvide Regulatory guidance for promotional press materials and scientific disclosures to media customers
Serve as key subject matter expert with Regulatory peers and business partners on topic(s) relevant to external medical device and mobile medical application communications (10% of time)​This is accomplished by:
    Actively monitoring external environment for updates on topic(s)Periodically share updates by presentation or summary reportsProvide ad hoc consultationEngage in external forums, including conferences
Exercise accountability for knowledge transfer across GRA (10% of time)
​This is accomplished by:
    Partnering with Device Regulatory Director and Device Regulatory Scientists from Global Regulatory Affairs (GRA) to consider FDA perspectives on device development requirements and relevance to advertising decisions and claimsDeveloping an understanding regarding the background of regulatory and marketing history of applicable productsRegularly communicating with other components in the GRA organization (i.e., device, labeling, central registration, regulatory intelligence) to facilitate sharing of information that allows the entire component to more effectively support product teamsBeing recognized as a technical expert in a specific area, product or a functional areaAttending internal and external training programs and educational forums, such as staff meetings, town halls, DIA, FDLI, AdvaMed and RAPS meetings.
  • Sharing lessons learned in forums such as GRA staff meetings
  • Contributing to the development of others by serving as a mentor for GRA personnelModeling the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Basic Qualifications
  • Bachelor's Degree
  • Minimum of 3 years of US regulatory advertising and promotion experience for medical devices, including software product and/or mobile medical applications
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences
  • Significant industry-related experience in drug development and/or commercialization
  • Comprehensive knowledge of FTC rules and decisions and FDA procedures and practices (CFR guidelines, Guidances, etc.)
  • Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)
  • Knowledge of regulatory/business strategies and plans.
  • Demonstrated ability to influence without authority
  • Demonstrated ability to deliver complex projects against a timeline
  • Strong communication skills (active listening, verbal, and written)
  • Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Additional Information
  • Minimum travel expected (
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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